An update on Personal Protective Equipment (PPE) regulations

Medical mask

Back in April I reported on the new export controls on specific PPE products that were identified as short supply for the US. FEMA issued a Federal Register Notice announcing the products that were banned from exporting from the United States along with a list of exemptions that were specific to some industries. FEMA issued the new regulation as a temporary regulation with a stated end date of August 7, 2020.

Effective on August 10, 2020, FEMA extended the end date of this regulation through December 31, 2020. The regulation keeps the same exemptions that allow exports to occur and also have the same process in working with Customs and Border Protection to review the export shipments to ensure adherence to the FEMA regulation. However, there are some changes to the identified products listed in the April regulation.  

Designation of covered materials:

  • (1) Surgical N95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;
  • (2) PPE surgical masks, including masks that cover the user’s nose and mouth and provide a physical barrier to fluids and particulate materials; 
  • (3) PPE nitrile gloves, including those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes; and
  • (4) Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by 
    Surgical Gown Barrier Performance based on AAMI PB70.

 

Upon determination that additional items are scarce and necessary for national defense, and that consideration under this allocation order is the only way to meet national defense requirements without significant disruption to the domestic markets, FEMA may designate additional materials as “covered materials” in the list provided above.

FEMA is eliminating two items from the covered materials list as there are currently no indications that supply is not meeting domestic demand to require these items to continue to be subject to this order.  FEMA is removing other filtering facepiece respirators, elastomeric, air-purifying respirators and appropriate particulate filters/cartridges from the list of covered materials. Note that this rule covers only those PPE items described above; it does not cover other forms of PPE not described in the rule, such as cloth-based masks.

As stated, the export process has not changed in the updated regulation so I would like to re-state the current process along with the exemptions that are permissible.

U.S. Customs and Border Protection (CBP), in coordination with such other officials as may be appropriate, will notify FEMA of an intended export of covered materials.  CBP must temporarily detain any shipment of such covered materials, pending the FEMA determination whether to return for domestic use or issue a rated order for part or all of the shipment, FEMA will make such a determination within a reasonable timeframe after notification of an intended export including the following factors: 

(7) The need to ensure that scarce or threatened items are appropriately allocated for domestic use; 
(8) Minimization of disruption to the supply chain, both domestically and abroad; 
(9) The circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns; 
(10) The quantity and quality of the materials; 
(11) Humanitarian considerations; and 
(12) International relations and diplomatic considerations.

Exemption: (1) FEMA has determined in the interest of promoting the national defense to generally allow the export of covered materials from shipments made by or on behalf of  U.S. manufacturers with continuous export agreements with customers in other countries since at least January 1, 2020, so long as at least 80 percent of such manufacturer’s domestic production of such covered materials, on a per item basis, was distributed in the United States in the preceding 12 months. If FEMA determines that a shipment of covered materials falls within this exemption, such materials may be exported without further review by FEMA, provided that the FEMA may waive this exemption and fully review shipments of covered materials under paragraph (b) of this section, if FEMA determines that doing so is necessary or appropriate to promote the national defense. FEMA will communicate to CBP regarding the application of this exemption to shipments identified by CBP.

FEMA may establish additional exemptions that he determines necessary or appropriate to promote the national defense and will announce any such exemptions by notice in the Federal Register.

Exportations prohibited: The exportation of covered materials other than in accordance with this section is prohibited. 

Most Federal Register notices allow comments from the industry to be sent, collected and reviewed by the US Government Agency. While reviewing this particular update there is not an opportunity for the industry to provide feedback on this regulation.

So my advice is to review the update, understand the export process, and if you seek an exemption you will need to contact FEMA. In the meantime stay well, stay safe, and as always if you have any questions about these details please do not hesitate to contact me.